There has been confusion on the representative sample of labeling needed to accompany a drug listing submission. Many companies submit all components currently to be conservative. Some submit only certain changes such as CBE's. However, this may be more difficult to do in the future especially since the SPL file will be available to the public. We will have to discuss in more detail with FDA.
2. Manufacturer Listing:
It has been difficult for many organizations to start comiling their drug listings because some of the manufacturers of their products have not yet listed. This is causing a bottleneck effect for some companies as this is a rate limiting step. Will the FDA allow for companies to drug list and use the FEI number of the establishment? We will have to bring this issue to FDA and see what can be done logistically.
3. Drug Listing Questions:
Many companies are still concerned that their drug listing is not correct. In the past, there used to be a deficiency letter that would be sent back if there were errors in the drug listing. Additionally, a Compliance Verification Report was printed and sent to the company to review and make sure that the information in the FDA database is accurate. Currently, many organizations are not aware if their submissions are adequate or if there are issues with them. Moving forward into the new process, some of these inadequacies may transpose themselves if the issues are not addressed prior to the change in procedure. The request was made again to meet with the Drug Listing division within FDA to ask some questions about the current process. Perhaps it would be beneificial to first set up a question log of any outstanding questions about the current process and that can lead us into a discussion with FDA. The suggestion will be brought up to FDA.
4. XFORMS:
There has been concern that XForms will not remain a free tool available to industry. Some organizations would like to rely on the XForms tool, but there have been rumors that a newer version without some of the glitches in the current version will become available soon but will have a fee included. According to the July 11th FR [Docket No. FDA–2005–N–0464], "a business may use a user-friendly
software (XForms)7 available at no cost for undustry use." It is not clear from this notice if this software is available for only the implementation period or thereafter. There will need to be a follow up on this topic.
5. Meeting with FDA on October 13, 2008 at 1 pm EDST
We will have a meeting with FDA on October 13, 2008 at 1 pm EDST where we have a mock drug listing session using a sample product and run through the drug listing steps. Meeting details will follow. FDA will be present along with D&B representatives. We will need to limit the number of callers because there are only a limited number of lines available.
6. Next meeting will be on October 8, 2008 at 1 pm EDST.
There has been confusion on the representative sample of labeling needed to accompany a drug listing submission. Many companies submit all components currently to be conservative. Some submit only certain changes such as CBE's. However, this may be more difficult to do in the future especially since the SPL file will be available to the public. We will have to discuss in more detail with FDA.
2. Manufacturer Listing:
It has been difficult for many organizations to start comiling their drug listings because some of the manufacturers of their products have not yet listed. This is causing a bottleneck effect for some companies as this is a rate limiting step. Will the FDA allow for companies to drug list and use the FEI number of the establishment? We will have to bring this issue to FDA and see what can be done logistically.
3. Drug Listing Questions:
Many companies are still concerned that their drug listing is not correct. In the past, there used to be a deficiency letter that would be sent back if there were errors in the drug listing. Additionally, a Compliance Verification Report was printed and sent to the company to review and make sure that the information in the FDA database is accurate. Currently, many organizations are not aware if their submissions are adequate or if there are issues with them. Moving forward into the new process, some of these inadequacies may transpose themselves if the issues are not addressed prior to the change in procedure. The request was made again to meet with the Drug Listing division within FDA to ask some questions about the current process. Perhaps it would be beneificial to first set up a question log of any outstanding questions about the current process and that can lead us into a discussion with FDA. The suggestion will be brought up to FDA.
4. XFORMS:
There has been concern that XForms will not remain a free tool available to industry. Some organizations would like to rely on the XForms tool, but there have been rumors that a newer version without some of the glitches in the current version will become available soon but will have a fee included. According to the July 11th FR [Docket No. FDA–2005–N–0464], "a business may use a user-friendly
software (XForms)7 available at no cost for undustry use." It is not clear from this notice if this software is available for only the implementation period or thereafter. There will need to be a follow up on this topic.
5. Meeting with FDA on October 13, 2008 at 1 pm EDST
We will have a meeting with FDA on October 13, 2008 at 1 pm EDST where we have a mock drug listing session using a sample product and run through the drug listing steps. Meeting details will follow. FDA will be present along with D&B representatives. We will need to limit the number of callers because there are only a limited number of lines available.
6. Next meeting will be on October 8, 2008 at 1 pm EDST.